Mintz Levin - Health Law & Policy Matters

FDA Makes More Electronic Submissions Mandatory

In recent months, the FDA has been pushing forward in its efforts to require that more information from regulated industry be submitted electronically. The move to electronic submissions should create a more efficient and…more
| Administrative Law, Health, Science, Computers, & Technology

21st Century Cures Legislation “Punts” on Telemedicine

On May 13, 2015, the House Energy and Commerce Committee released the latest draft of its 21st Century Cures Legislation. The proposed legislation includes certain telehealth-related provisions that, among other things, request…more
| Health, Science, Computers, & Technology

More Biosimilar Q&A’s Released by FDA

After finalizing three key guidance documents on biosimilars at the end of April (reported on our blog here), yesterday FDA released another “Question and Answer” guidance in draft form. The draft guidance is called…more
| Administrative Law, Health, Intellectual Property, Science, Computers, & Technology

CMS Changes Medicare Prescriber Enrollment Requirements

On May 6, 2015, CMS issued interim final rules relating to Medicare Part D beneficiary access to Part D drugs. Through the rules, CMS announced updates regarding the impending prescriber enroll or opt-out effective date,…more
| Health, Science, Computers, & Technology

Is Your Pharmacy Ready for Drug Supply Chain Integrity?

Beginning July 1, 2015, most pharmacies in the U.S. will be required to have systems in place to receive transaction information regarding the prescription drugs they purchase from suppliers. The requirement stems from a 2013…more
| Commercial Law & Contracts, Health, Science, Computers, & Technology

ONC Releases Privacy and Security Guidance Geared Toward Small Providers

The HHS Office of the National Coordinator for Health Information Technology (“ONC”) recently released a new and improved version 2.0 of their Guide to Privacy and Security of Electronic Health Information. This revamped…more
| Health, Privacy

Medicare Part D Data Release Continues Transparency Trend

The Centers for Medicare & Medicaid Services (CMS) recently added to the trend toward greater health care data transparency by releasing data about the prescription drugs that physicians and other health care providers…more
| Health, Science, Computers, & Technology

FTC Says New York’s Medicaid Redesign Program May Promote Anticompetitive Behavior

In an April 22, 2015 letter to the New York State Department of Health (DOH), the Federal Trade Commission (FTC) cautioned that part of the State’s Medicaid reform program may sanction anticompetitive behavior. The FTC’s concern…more
| Antitrust & Trade Regulation, Health

GAO Report Analyzes Options for Medicare Card Technology

Historically, the Center for Medicare and Medicaid Services (“CMS“) issues all Medicare beneficiaries a paper card that includes the beneficiary’s name, Medicare number and eligibility status. Beneficiaries present the cards to…more
| Health

Proposed GME Legislation Looks to Increase Residency Slots

Last week, new bi-partisan legislation was introduced to increase the number of graduate medical education (GME) slots over the next five years at teaching hospitals and academic medical centers. If passed, the Resident…more
| Education, Health

FDA Finalizes Key Guidance Documents on Biosimilars

On the heels of its approval of the first biosimilar product in March, FDA has just released final versions of three key biosimilar guidance documents under the Biologics Price Competition and Innovation Act (BPCIA). The newly…more
| Administrative Law, Health, Science, Computers, & Technology

Data Breach Nightmare Scenario: News Affiliate Reports Improper Disposal of Patient Information

A tip from a local Denver news outlet lead to a compliance review, investigation and ultimately a resolution agreement between the Department of Health and Human Services’ Office for Civil Rights (“OCR”) and Denver-based Cornell…more
| Consumer Protection, Health, Privacy

States Move to Impose Limits on Biosimilar Drug Substitution

In early April, Colorado joined multiple other states in passing a biosimilar substitution law that addresses the circumstances under which an FDA-approved interchangeable biosimilar product may be substituted for the prescribed…more
| Health, Science, Computers, & Technology

MACRA’s Advancement of EHR Interoperability and Telehealth

This is the fourth and final post in our series on the Medicare Access and CHIP Reauthorization Act (MACRA). Pub.L. No. 114-10. We’ve previously covered the repeal of the Sustainable Growth Rate (SGR) in our April 20th post,…more
| Consumer Protection, Government Contracting, Health, Privacy, Science, Computers, & Technology

MACRA: Program Integrity and Fraud and Abuse Provisions

On Thursday April 16th, President Obama signed into law the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”). Pub.L. 114-10. In two previous posts, we discussed MACRA’s repeal of the Sustainable Growth Rate formula…more
| Elections & Politics, Health
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701 Pennsylvania Avenue, N.W.
Washington, DC 20004-2608, United States

  • 202-434-7324
  • 202-434-7400

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